Gilteritinib Side Effects

Medically reviewed by Drugs.com. Last updated on May 11, 2024.

Applies to gilteritinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur as early as 1 day after starting this medicine and during the first 3 months of treatment. Check with your doctor right away if you start to have a fever, cough, trouble breathing, swelling of the arms or legs or around the neck, groin, or underarms, rapid weight gain, or bone pain. Your doctor may give you a steroid medicine (eg, dexamethasone) to help treat these symptoms.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

Check with your doctor right away if you have loss of appetite, nausea, or pains in stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of gilteritinib

Along with its needed effects, gilteritinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking gilteritinib:

Other side effects of gilteritinib

Some side effects of gilteritinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to gilteritinib: oral tablet.

Hypersensitivity adverse events

• Common (1% to 10%): Anaphylactic reaction^[Ref]

Immunologic

• Very common (10% or more): Pneumonia (15%), sepsis (15%)^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia/arthralgia (e.g., arthralgia, back pain, bone pain, myalgia, musculoskeletal pain, neck pain, non-cardiac chest pain, pain in extremity) (42%)^[Ref]

Metabolic

• Very common (10% or more): Hyperglycemia (86%), hypocalcemia (61%), edema (34%), hyponatremia (32%), decreased appetite (15%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (14%)^[Ref]

Hepatic

• Very common (10% or more): Increased transaminases (aspartate aminotransferase increased, alanine aminotransferase increased, transaminases increased, liver function test increased, hepatic failure, hepatocellular injury, hepatotoxicity) (41%), bilirubin increased (11%)^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (34%), pneumonia (30%), cough (25%)^[Ref]

Other

• Very common (10% or more): Fatigue/malaise (40%), fever (35%)
• Common (1% to 10%): Differentiation syndrome^[Ref]

Nervous system

• Very common (10% or more): Headache (21%), dizziness (20%), dysgeusia (11%)
• Common (1% to 10%): Posterior reversible encephalopathy syndrome (PRES)^[Ref]

Renal

• Very common (10% or more): Renal impairment (e.g., acute kidney injury, blood creatinine increased, chronic kidney disease, oliguria, renal disorder, renal

failure, renal impairment, renal injury, renal tubular necrosis) (19%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (30%), hypertension (10%)
• Common (1% to 10%): Prolonged QT interval, cardiac failure (e.g., cardiac failure, cardiac failure congestive, cardiomyopathy, cardiomegaly, chronic left ventricular failure, ejection fraction decreased), pericardial effusion, pericarditis^[Ref]

Dermatologic

• Very common (10% or more): Rash (30%)^[Ref]

Gastrointestinal

• Very common (10% or more): Noninfectious diarrhea (34%), nausea (27%), stomatitis (26%), vomiting (20%), abdominal pain (e.g., abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, epigastric discomfort, GI pain) (17%)^[Ref]

See also:

Frequently asked questions

• What type of leukemia is Xospata (gilteritinib) used to treat?

Further information

Gilteritinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer